Ireland
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Recruiting Phase 3

Ensifentrine (MK-5884) Study for the Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in Adults With a History of Moderate or Severe Exacerbations While Receiving Standard of Care (SOC) (MK-5884-031/RPL554/ENHANCE-3)

NCT07874815 · tracked via the Priya Life Science USA tracker
Phase
Phase 3
Started
2026-11-02
Last updated
2026-11-06

Condition(s) studied

Pulmonary Disease, Chronic Obstructive

Investigational drug(s) / intervention(s)

Ensifentrine →PlaceboStandard of Care (SOC)

Ensifentrine: Delivered twice daily by oral inhalation via a standard jet nebulizer

Placebo: Placebo matched to ensifentrine delivered twice daily by oral inhalation via a standard jet nebulizer

Standard of Care (SOC): Background treatment of LAMA/LABA/ICS or LAMA/LABA (if ICS is not appropriate) administered per product approved label delivered by oral inhalation as part of standard of care

Study summary

The purpose of this study is to evaluate the efficacy and safety of ensifentrine (MK-5884) compared with placebo for the prevention of moderate and severe COPD exacerbation in adults with COPD and a history of exacerbations while receiving SOC treatment. The study will also evaluate the efficacy of ensifentrine compared with placebo in improving lung function, improving health related quality of life, and preventing severe exacerbations.

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: Inclusion Criteria include but are not limited to: * Has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) that was made ≥12 months prior to randomization * Has been on the stable treatment with the same standard of care (SOC) with long-acting muscarinic antagonist (LAMA)/long-acting beta-2 agonist (LABA)/inhaled corticosteroid (ICS) or LAMA/LABA (if ICS is not appropriate), for at least 2 months prior to Screening * Has a documented history of ≥1 moderate or severe COPD exacerbation while on standard of care (SOC) within 1 year of Screening * Is a current or former cigarette smoker with a history of cigarette smoking ≥10 packyears at Screening (number of pack-years = \[number of cigarettes per day/20\] × number of years smoked \[e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years\]). Pipe, cigar, and/or e-cigarette/vape use cannot be used to calculate pack-year history. * Has post-bronchodilator forced expiratory volume 1 (FEV1) ≥25% and \<70% of Predicted Normal Value Exclusion Criteria: Exclusion criteria include but are not limited to: * Has a history of intubation for respiratory failure within 1 year of Screening * Is receiving long-term oxygen therapy defined as \>15 hours per day * Uses chronic bilevel positive airway pressure for treatment of respiratory condition unless for treatment of sleep apnea at a stable pressure for at least 3 months * Is currently using or has used a biologic therapy (e.g., dupilumab, mepolizumab, or tozorakimab) within 6 months prior to Screening Visit * Has history of or current malignancy of any organ system, treated or untreated within the past 5 years, except for localized basal or squamous cell carcinoma of the skin.

Primary outcome measure(s)

  • Annualized Rate of Adjudicated Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations — Up to 52 Weeks
    The annualized rate of moderate or severe exacerbations over 52 weeks will be reported.

Trial sites (7)

FacilityCityRegionStatus
Family First Medical Research Center ( Site 4458) Hialeah Gardens Florida Recruiting
Advanced Pulmonary Research Institute ( Site 4427) Loxahatchee Groves Florida Recruiting
Velocity Clinical Research ( Site 4464) Valparaiso Indiana Recruiting
CHEAR Center LLC ( Site 4407) The Bronx New York Recruiting
Lowcountry Lung & Critical Care, PA ( Site 4413) Charleston South Carolina Recruiting
M3 Wake Research, Inc. ( Site 4440) Chattanooga Tennessee Recruiting
Victoria Clinical Research Group ( Site 4430) Victoria Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07874815 on ClinicalTrials.gov ↗ ← All trials in the USA